DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice of Amendment
In response to the amendment filed on 10/27/2025, amended claims 1, 12, 18, and 20 are acknowledged. Claims 1-22 remain pending. The following new and reiterated grounds of rejection are set forth:
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 5, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belson (US Publication No. 2004/0034383 A1) (previously cited), further in view of Chuttani et al. (US Patent No. 5,054,501) (previously cited).
Regarding claim 1, Belson discloses a coil wire for navigation of blood vessels of a body of a patient, the coil wire comprising:
a proximal portion (106), a middle portion (see Figure 1) and a distal portion (108), the proximal portion having proximal and distal ends and being tapered such that a diameter of the proximal end is larger than a diameter of the distal end (see [0020] – “For example, the flow-directed member 104 may be mounted to the distal end of a conventional guidewire or spring guide with an elongated guide body that is constructed with a tapered core wire to provide a very flexible tip and gradually increasing stiffness in the proximal direction”), the middle portion having proximal and distal ends and being tapered such that the proximal end of the middle portion has a diameter that is substantially equal to the diameter of the distal end of the proximal portion, the distal end of the middle portion having a diameter that is smaller than the diameter of the proximal end of the middle portion (see [0020] – “For example, the flow-directed member 104 may be mounted to the distal end of a conventional guidewire or spring guide with an elongated guide body that is constructed with a tapered core wire to provide a very flexible tip and gradually increasing stiffness in the proximal direction”), the distal portion having proximal and distal ends, the distal end of the proximal portion being coupled to the proximal end of the middle portion (see Figure 1), the distal end of the middle portion being coupled to the proximal end of the distal portion (see Figure 1), the distal portion comprising a flow-directed member (104) having a proximal end and a distal end, the flow-directed member being configured to be flow-directed such that if blood flow of an intended blood vessel exerts a deflection force on the flow-directed member, the deflection force exerted on the flow-directed member by the blood flow causes the flow-directed member to unfurl from a furled state into an unfurled state and to be directed in a direction of the blood flow of the intended blood vessel (see Figure 3 and [0022] – “The flow-directed member 104 may be deployed by advancing the actuation wire 116 from the proximal end 106 of the catheter guide shaft 102 to push the parachute shroud 120 out of the chamber 118 on the distal end 108 of the elongated shaft 102”).
It is noted Belson does not specifically teach the flow-directed member is a coil. However, Chuttani et al. teaches a distal portion (12) comprising a coil (15) having a proximal end (see Figure 1) and a distal end (28), the coil being configured to be flow-directed such that if blood flow of an intended blood vessel exerts a sufficient force on the coil, the force exerted on the coil by the blood flow causes the flow-directed member to unfurl from a furled state (see Figure 2) into an unfurled state (see Figure 1) and to be directed in a direction of the blood flow of the intended blood vessel (see col. 2, lines 29-40 – “More specifically, the distal end of the guide wire is formed with a plurality of coils forming a helix. The coils are formed so that the helix has an outer diameter greater than the diameter of the distal end of the guide wire when the helix is in the free position. Because the guide wire is flexible, the helix can be straightened or elongated when subject to external forces, such as those induced when the guide wire is passed into a narrow catheter, and the outer diameter of the helix can be reduced to the point where it approaches the diameter of the guide wire shaft at the distal end”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Belson to include a flow-directed member that is a coil, as disclosed in Chuttani et al., so as to aid in negotiation through tubular or vascular organs (see Chuttani et al.: Abstract).
Regarding claim 2, the combination of Belson and Chuttani et al. teaches the coil wire is configured to allow a catheter (Belson: 102; Chuttani et al.: 50) to be advanced over the coil wire into a position in the intended blood vessel when the coil is in the unfurled state and to allow the coil wire to be withdrawn from the intended blood vessel of the patient through the catheter after the catheter is in said position (see Belson: Figures 2-3 and Chuttani et al.: see Figures 1-2).
Regarding claim 3, the combination of Belson and Chuttani et al. teaches the proximal portion, the middle portion and the distal portion are integrally formed as a single piece part (see Belson: Figure 1 and Chuttani et al.: see Figure 1).
Regarding claim 5, the combination of Belson and Chuttani et al. teaches the coil wire is tapered such the coil wire has a first diameter at the proximal end of the proximal portion that is larger than a second diameter of the coil wire at the distal end of the middle portion and has a continuously decreasing diameter over a length of the coil wire extending at least from the proximal end of the proximal portion to the distal end of the middle portion (see Belson: [0020] – “For example, the flow-directed member 104 may be mounted to the distal end of a conventional guidewire or spring guide with an elongated guide body that is constructed with a tapered core wire to provide a very flexible tip and gradually increasing stiffness in the proximal direction” and Chuttani et al.: col. 3, lines 20-24 – “To facilitate increased flexibility at the distal end, the preferred embodiment of the wire shaft (10) decreases in diameter throughout a tapered portion (16) near the distal end (12) of the guide wire (5)”).
Regarding claim 16, the combination of Belson and Chuttani et al. teaches the proximal and distal portions of the coil wire comprise a guidewire (see Belson: [0020] – “For example, the flow-directed member 104 may be mounted to the distal end of a conventional guidewire or spring guide with an elongated guide body that is constructed with a tapered core wire to provide a very flexible tip and gradually increasing stiffness in the proximal direction” and Chuttani et al.: col. 3, line 13 – “steerable guide wire”).
Regarding claim 17, the combination of Belson and Chuttani et al. teaches the proximal and distal portions of the coil wire comprise a hypodermic tube (hypo-tube) (see Belson: [0020] – “Alternatively, the flow-directed member 104 described herein may be mounted on a catheter guide or catheter of more conventional construction”).
Regarding claim 18, it is noted the combination of Belson and Chuttani et al. does not specifically teach a combined length for the proximal portion and the distal portion ranges from about 150 to about 250 centimeters (cm), a length of the coil in the furled state ranging from about 1.5 millimeters (mm) to about 2.5 mm, a length of the coil in the unfurled state ranging from about 4.0 mm to about 7.0 mm, the diameter of the proximal end of the proximal portion ranging from about 0.005 inches to about 0.025 inches, and a diameter of the distal tip of the coil being less than or equal to about .010 inches. However, it would have been an obvious matter of design choice to modify the combination of Belson and Chuttani et al. to have a device with a combined length for the proximal portion and the distal portion ranges from about 150 to about 250 centimeters (cm), a length of the coil in the furled state ranging from about 1.5 millimeters (mm) to about 2.5 mm, a length of the coil in the unfurled state ranging from about 4.0 mm to about 7.0 mm, the diameter of the proximal end of the proximal portion ranging from about 0.005 inches to about 0.025 inches, and a diameter of the distal tip of the coil being less than or equal to about .010 inches, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 4, 6-14, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belson and Chuttani et al., further in view of Carter et al. (US Patent No. 8,715,205 B2) (previously cited).
Regarding claim 4, it is noted neither Belson nor Chuttani et al. specifically teach the proximal portion and the middle portion are integrally formed as a single piece part, and wherein the distal portion is formed as a piece part that is separate from the proximal and middle portions, the coil wire further comprising: an attachment mechanism disposed at a transition region where the distal end of the middle portion couples to the proximal end of the distal portion, the attachment mechanism coupling the distal end of the middle portion to the proximal end of the distal portion. However, Carter et al. teaches the proximal portion (26) and the middle portion (22) are integrally formed as a single piece part, and wherein the distal portion (30) is formed as a piece part that is separate from the proximal and middle portions, the coil wire further comprising: an attachment mechanism (29, 33) disposed at a transition region where the distal end of the middle portion couples to the proximal end of the distal portion, the attachment mechanism coupling the distal end of the middle portion to the proximal end of the distal portion (see col. 4, lines 6-15 – “As shown in FIG. 1, the connecting structure 32 is formed where the connector 29 of the shaft 22 joins the connector 33 of the loop 30. The connecting structure 32 may have a smooth outer surface 35 for facilitating passage through the body lumen. Exemplary connecting configurations are discussed below, however any configuration for connecting the loop 30 and the shaft 22 may be used. By way of non-limiting example, connecting configurations where the first connector 29 interlocks with the second connector 33 may include snap-fit, threads, clips, adhesives and magnets”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Belson and Chuttani et al. to include the proximal portion and the middle portion are integrally formed as a single piece part, and wherein the distal portion is formed as a piece part that is separate from the proximal and middle portions, the coil wire further comprising: an attachment mechanism disposed at a transition region where the distal end of the middle portion couples to the proximal end of the distal portion, the attachment mechanism coupling the distal end of the middle portion to the proximal end of the distal portion, as disclosed in Carter et al., so as to releasably interlock the distal portion to the middle portion (see Carter et al.: col. 3, lines 50-52).
Regarding claim 6, it is noted neither Belson nor Chuttani et al. specifically teach the coil wire is made of a metallic material to provide the coil wire with radio opacity. However, Carter et al. teaches the coil wire is made of a metallic material to provide the coil wire with radio opacity (see col. 8, lines 31-51 – “Radiopaque materials may be added in the coating. Also, radiopaque materials known in the art may be placed on the shaft 22 and the loop 30 and other portions of the wire guide 20. Several examples of suitable radiopaque materials and markers are known in the art, and any suitable material and/or marker can be utilized in the present invention. Common radiopaque materials include barium sulfate, bismuth subcarbonate, and zirconium dioxide. Other radiopaque elements include: cadmium, tungsten, gold, tantalum, bismuth, platinum, iridium, and rhodium. In one embodiment, iodine may be employed for its radiopacity and antimicrobial properties. Radiopacity is typically determined by fluoroscope or x-ray film. Radiopaque, physiologically compatible materials include metals and alloys selected from the Platinum Group metals, especially platinum, rhodium, palladium, rhenium, as well as tungsten, gold, silver, tantalum, and alloys of these metals. These metals have significant radiopacity and in their alloys may be tailored to accomplish an appropriate blend of flexibility and stiffness. They are also largely biocompatible. For example, a platinum/tungsten alloy, e.g., 8% tungsten and the remainder platinum may be used”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Belson and Chuttani et al. to include the coil wire is made of a metallic material to provide the coil wire with radio opacity, as disclosed in Carter et al., so as to allow the device to be tracked using conventional imaging techniques.
Regarding claim 7, Carter et al. teaches the coil wire comprises Nickel-Titanium (Nitinol) (see col. 6, line 63-col. 7, line 7 – “Any suitable material can be used for the wire guide 20 and portions thereof. The material chosen need only be biocompatible, or made biocompatible, and able to be formed into the structures described herein. Exemplary materials will also be compliant, elastic, resilient and have shape memory. Portions of the wire guide 20, such as the loop 30 and the shaft 22 may be made from different materials or the same materials. Examples of suitable materials include, but are not limited to stainless steel, tantalum, nitinol; gold, silver, tungsten, platinum, inconel, cobalt-chromium alloys and iridium, all of which are commercially available metals or alloys used in the fabrication of medical devices”).
Regarding claim 8, Carter et al. teaches the coil wire comprises steel (see col. 6, line 63-col. 7, line 7 – “Any suitable material can be used for the wire guide 20 and portions thereof. The material chosen need only be biocompatible, or made biocompatible, and able to be formed into the structures described herein. Exemplary materials will also be compliant, elastic, resilient and have shape memory. Portions of the wire guide 20, such as the loop 30 and the shaft 22 may be made from different materials or the same materials. Examples of suitable materials include, but are not limited to stainless steel, tantalum, nitinol; gold, silver, tungsten, platinum, inconel, cobalt-chromium alloys and iridium, all of which are commercially available metals or alloys used in the fabrication of medical devices”).
Regarding claim 9, Carter et al. teaches the coil wire comprises cobalt-chromium (see col. 6, line 63-col. 7, line 7 – “Any suitable material can be used for the wire guide 20 and portions thereof. The material chosen need only be biocompatible, or made biocompatible, and able to be formed into the structures described herein. Exemplary materials will also be compliant, elastic, resilient and have shape memory. Portions of the wire guide 20, such as the loop 30 and the shaft 22 may be made from different materials or the same materials. Examples of suitable materials include, but are not limited to stainless steel, tantalum, nitinol; gold, silver, tungsten, platinum, inconel, cobalt-chromium alloys and iridium, all of which are commercially available metals or alloys used in the fabrication of medical devices”).
Regarding claim 10, Carter et al. teaches the proximal and middle portions comprise a first metallic material and the coil comprises a second metallic material (see col. 6, line 63-col. 7, line 7 – “Any suitable material can be used for the wire guide 20 and portions thereof. The material chosen need only be biocompatible, or made biocompatible, and able to be formed into the structures described herein. Exemplary materials will also be compliant, elastic, resilient and have shape memory. Portions of the wire guide 20, such as the loop 30 and the shaft 22 may be made from different materials or the same materials. Examples of suitable materials include, but are not limited to stainless steel, tantalum, nitinol; gold, silver, tungsten, platinum, inconel, cobalt-chromium alloys and iridium, all of which are commercially available metals or alloys used in the fabrication of medical devices”).
Regarding claim 11, Carter et al. teaches the first metallic material is selected from the group comprising Nitinol, steel and cobalt-chromium and the second metallic material comprises platinum (see col. 6, line 63-col. 7, line 7 – “Any suitable material can be used for the wire guide 20 and portions thereof. The material chosen need only be biocompatible, or made biocompatible, and able to be formed into the structures described herein. Exemplary materials will also be compliant, elastic, resilient and have shape memory. Portions of the wire guide 20, such as the loop 30 and the shaft 22 may be made from different materials or the same materials. Examples of suitable materials include, but are not limited to stainless steel, tantalum, nitinol; gold, silver, tungsten, platinum, inconel, cobalt-chromium alloys and iridium, all of which are commercially available metals or alloys used in the fabrication of medical devices”).
Regarding claim 12, the combination of Belson and Chuttani et al. teaches the coil of the distal portion possesses shape-ability, the shape-ability allowing the coil to unfurl from the furled state into the unfurled state when the deflection force of blood flow exerted on the coil is sufficient to cause the coil to unfurl from the furled state into the unfurled state (see Belson: Figure 3 and [0022] – “FIG. 3 shows the distal end 108 of the catheter guide 100 of FIG. 1 with the flow-directed member 104 in a deployed state. The flow-directed member 104 may be deployed by advancing the actuation wire 116 from the proximal end 106 of the catheter guide shaft 102 to push the parachute shroud 120 out of the chamber 118 on the distal end 108 of the elongated shaft 102”). It is noted neither Belson nor Chuttani et al. specifically teach the coil of the distal portion possesses shape memory, the shape memory causing the coil to attempt to return to the furled state from the unfurled state when the deflection force of the blood flow exerted on the coil is less than said sufficient force. However, Carter et al. teaches the coil of the distal portion possesses shape memory, the shape memory causing the coil to attempt to return to the furled state from the unfurled state when the deflection force of the blood flow exerted on the coil is less than said sufficient force (see col. 6, lines 63-67 – “Any suitable material can be used for the wire guide 20 and portions thereof. The material chosen need only be biocompatible, or made biocompatible, and able to be formed into the structures described herein. Exemplary materials will also be compliant, elastic, resilient and have shape memory”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Belson and Chuttani et al. to include the coil of the distal portion possesses shape memory, the shape memory causing the coil to attempt to return to the furled state from the unfurled state when the deflection force of the blood flow exerted on the coil is less than said sufficient force, as disclosed in Carter et al., so as to facilitate navigation and reduce trauma to the lumen wall during advancement of the wire guide (see Carter et al.: col. 1, lines 51-55).
Regarding claim 13, the combination of Belson and Chuttani et al. teaches the coil in the furled state is substantially helical in shape (see Chuttani et al.: Figures 1-2).
Regarding claim 14, the combination of Belson and Chuttani et al. teaches a tip of the distal end of the coil when the coil is in the unfurled state is curved so as to be nonparallel to a center axis of the coil when the coil is in the furled state, the curved tip of the distal end of the coil being atraumatic to the selected vessel (see Chuttani et al.: Figures 1-2 and col. 3, lines 17-20 – “The distal end (12) of the guide wire (5) has a plurality of individual coils (20) forming a helix (15) which, in the preferred embodiment, terminates into a distal tip (25) and a soft rounded end (28)”).
Regarding claim 19, it is noted neither Belson nor Chuttani et al. specifically teach an attachment mechanism that couples the distal end of the middle portion to the proximal end of the distal portion, wherein the distal portion is detachable from the middle portion by manipulating the attachment mechanism. However, Carter et al. teaches an attachment mechanism (29, 33) that couples the distal end of the middle portion to the proximal end of the distal portion, wherein the distal portion is detachable from the middle portion by manipulating the attachment mechanism (see col. 4, lines 6-15 – “As shown in FIG. 1, the connecting structure 32 is formed where the connector 29 of the shaft 22 joins the connector 33 of the loop 30. The connecting structure 32 may have a smooth outer surface 35 for facilitating passage through the body lumen. Exemplary connecting configurations are discussed below, however any configuration for connecting the loop 30 and the shaft 22 may be used. By way of non-limiting example, connecting configurations where the first connector 29 interlocks with the second connector 33 may include snap-fit, threads, clips, adhesives and magnets”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Belson and Chuttani et al. to include an attachment mechanism that couples the distal end of the middle portion to the proximal end of the distal portion, wherein the distal portion is detachable from the middle portion by manipulating the attachment mechanism, as disclosed in Carter et al., so as to releasably interlock the distal portion to the middle portion (see Carter et al.: col. 3, lines 50-52).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belson, Chuttani et al., and Carter et al., further in view of Hoganson et al. (US Patent No. 9,162,039 B2) (previously cited).
Regarding claim 15, it is noted none of Belson, Chuttani et al., or Carter et al. specifically teach the distal end of the middle portion is bendable into a bent state to allow improved control over vessel selection by a user who manipulates the proximal end of the proximal portion of the coil wire to select the intended vessel. However, Hoganson et al. teaches the distal end of the middle portion (64) is bendable into a bent state to allow improved control over vessel selection by a user who manipulates the proximal end of the proximal portion of the coil wire to select the intended vessel (see Figures 12-14 and col. 11, lines 33-45 – “The steerable portion 64 may be flexed or bent at the direction of the operator to angle the distal portion of the guidewire within a vessel. FIG. 13 shows the guidewire 60 with its distal portion 62 bent at an angle with respect to the proximal portion 68 as the steerable portion 64 forms a gentle curve. FIG. 14 is another view of the guidewire 60 with the distal portion 62 approximately parallel to the proximal portion 68 by nature of a marked curve formed by the steerable portion 64. The steerable portion 64 may be able to bend up to or further than a 180 degree angle. This feature is important for allowing the sail to be directed within the aorta towards a desired head or arm vessel”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Belson, Chuttani et al., and Carter et al. to include the distal end of the middle portion is bendable into a bent state to allow improved control over vessel selection by a user who manipulates the proximal end of the proximal portion of the coil wire to select the intended vessel, as disclosed in Hoganson et al., so as to allow the coil to be directed towards the intended vessel (see Hoganson et al.: col. 11, lines 43-45).
Claim(s) 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belson and Chuttani et al., further in view of Hoganson et al.
Regarding claim 20, Belson teaches a method for navigating blood vessels of a body of a patient, the method comprising:
providing a coil wire comprising proximal portion (106), a middle portion (see Figure 1) and a distal portion (108), the proximal portion having proximal and distal ends, the middle portion having proximal and distal ends and the distal portion having proximal and distal ends, the distal end of the proximal portion being coupled to a proximal end of the middle portion, the distal end of the middle portion being coupled to the proximal end of the distal portion, the distal portion comprising a flow-directed member having a proximal end and a distal end, the a flow-directed member being configured to be flow-directed such that if blood flow of an intended blood vessel exerts a deflection force on the a flow-directed member, the deflection force exerted on the a flow-directed member by the blood flow causes the a flow-directed member to unfurl from a furled state into an unfurled state and to be directed in a direction of the blood flow of the intended blood vessel (see Figure 3 and [0022] – “The flow-directed member 104 may be deployed by advancing the actuation wire 116 from the proximal end 106 of the catheter guide shaft 102 to push the parachute shroud 120 out of the chamber 118 on the distal end 108 of the elongated shaft 102”).
It is noted Belson does not specifically teach the flow-directed member is a coil. However, Chuttani et al. teaches a distal portion (12) comprising a coil (15) having a proximal end (see Figure 1) and a distal end (28), the coil being configured to be flow-directed such that if blood flow of an intended blood vessel exerts a sufficient force on the coil, the force exerted on the coil by the blood flow causes the flow-directed member to unfurl from a furled state (see Figure 2) into an unfurled state (see Figure 1) and to be directed in a direction of the blood flow of the intended blood vessel (see col. 2, lines 29-40 – “More specifically, the distal end of the guide wire is formed with a plurality of coils forming a helix. The coils are formed so that the helix has an outer diameter greater than the diameter of the distal end of the guide wire when the helix is in the free position. Because the guide wire is flexible, the helix can be straightened or elongated when subject to external forces, such as those induced when the guide wire is passed into a narrow catheter, and the outer diameter of the helix can be reduced to the point where it approaches the diameter of the guide wire shaft at the distal end”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Belson to include a flow-directed member that is a coil, as disclosed in Chuttani et al., so as to aid in negotiation through tubular or vascular organs (see Chuttani et al.: Abstract).
Chuttani et al. describes a specific use case in the gall bladder (see Figures 5-6) and therefore does not specifically teach advancing the coil to a branch point where the intended blood vessel and another blood vessel branch. However, Hoganson et al. teaches advancing the coil to a branch point where the intended blood vessel (110) and another blood vessel (104, 112) branch (see Figures 18-21 and col. 14, lines 19-49 – “The sail 30 has opened and is currently positioned in the arch of the aorta. It is near the orifice of the innominate artery 104 and may be directed by the flow into this branch vessel. If placement of the guidewire into the vessel is desired, the flex in the guidewire may be reduced, allowing the guidewire to straighten slightly and with gentle advancement, the guidewire may enter the innominate artery 104. For this example, the guidewire will be directed into the left common carotid artery 110. To do so, the guidewire is retracted in the flexed position as shown in FIG. 19. As it is pulled back through the aorta it will near the orifice of the left common carotid artery as is shown in FIG. 20. To advance the guidewire into the left common carotid artery 110, the guidewire is straightened slightly. With some advancement, the flow will direct the guidewire 68 into the orifice of the left common carotid artery 110. FIG. 21 shows the tip of the guidewire 60 with the sail 30 in the left common carotid artery 110. At this point, the guidewire, depending on its size and the pathology within the common carotid artery the guidewire could be advanced past a lesion in the common or internal carotid artery or it could be exchanged for a simple tubular catheter instead of a more expensive traditional guiding catheter. Additional guidewires, angioplasty balloons, distal protection devices, stents or other devices could be passed though this simple tubular catheter. With this easily controlled device, a guidewire may be positioned from the aorta into a desired branch vessel with minimal or no contact with the wall of the aorta and with improved ease compared to the currently available technology. This is simply one application for this technology. Accessing other vessels or selecting between branches of other vessels may also be desirable”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Belson and Chuttani et al. to include advancing the coil to a branch point where the intended blood vessel and another blood vessel branch, as disclosed in Hoganson et al., so as to position the guidewire in the desired branch vessel with minimal or no contact with the wall of the vessel and with improved ease compared to the currently available technology (see Hoganson et al.: col. 14, lines 43-47).
The combination of Belson, Chuttani et al., and Hoganson et al. further teaches allowing the coil to unfurl into the unfurled state as directed by the blood flow such that the distal end of the coil passes within the intended blood vessel to a desired location within the intended blood vessel (see Belson: Abstract – “The flow-directed member can be deployed to direct the distal end of the catheter guide downstream following the blood flow in the vessel”);
advancing a catheter over the coil wire into the intended blood vessel (see Hoganson et al.: col. 14, lines 36-43 – “At this point, the guidewire, depending on its size and the pathology within the common carotid artery the guidewire could be advanced past a lesion in the common or internal carotid artery or it could be exchanged for a simple tubular catheter instead of a more expensive traditional guiding catheter. Additional guidewires, angioplasty balloons, distal protection devices, stents or other devices could be passed though this simple tubular catheter”).
removing the coil wire from the body of the patient and from the catheter (see Chuttani et al.: col. 5, lines 54-55 – “The guide wire (5) and the catheter (50) are then both removed from the patient”).
Regarding claim 21, Chuttani et al. teaches manipulating the coil within the intended blood vessel to obtain biopsy cells (see col. 5, lines 20-30 – “Once the guide wire (5) is within the gallbladder (95) or in the desired position, the pre-shaped catheter (50) can be gently withdrawn. The guide wire (5) is then in proper position for advanced stages of the procedure, for example to allow a mini-endoscope to be passed over it and into the gallbladder (95) for diagnosis and treatment. Such a mini-endoscope could be used to directly visualize the cystic duct (60) and gallbladder (95) pathology, or facilitate the extraction of brushings or biopsies from benign or malignant gallbladder lesions”).
Regarding claim 22, Chuttani et al. teaches separating the biopsy cells from the coil (see col. 5, lines 20-30 – “Once the guide wire (5) is within the gallbladder (95) or in the desired position, the pre-shaped catheter (50) can be gently withdrawn. The guide wire (5) is then in proper position for advanced stages of the procedure, for example to allow a mini-endoscope to be passed over it and into the gallbladder (95) for diagnosis and treatment. Such a mini-endoscope could be used to directly visualize the cystic duct (60) and gallbladder (95) pathology, or facilitate the extraction of brushings or biopsies from benign or malignant gallbladder lesions”).
Response to Arguments
Applicant's arguments filed 10/27/2025 have been fully considered but they are not persuasive.
Applicant argues that Belson does not disclose or suggest that the catheter guide is a coil wire. However, Belson explicitly states “the flow-directed member 104 may be mounted to the distal end of a conventional guidewire or spring guide” (see [0020]) and further explains that such structures are well-known in the art to include “a coiled wire spring surrounding a core wire” (see [0005]). To suggest that Belson, in at least some embodiments, does not describe a coil wire, is a misreading of what Belson plainly describes.
Applicant then argues that Belson does not teach or suggest that the alleged wire comprises a proximal portion and a middle portion that are tapered. Again, Belson explicitly states “the flow-directed member 104 may be mounted to the distal end of a conventional guidewire or spring guide with an elongated guide body that is constructed with a tapered core wire to provide a very flexible tip and gradually increasing stiffness in the proximal direction” (see [0020]). Again, it is unclear how Applicant is interpreting this to suggest there is no taper when Belson explicitly states the spring guide is tapered.
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Thus, Applicant’s argument that Chuttani does not disclose or suggest that the helix is unfurled by blood flow or is directed by blood flow is not persuasive because Belson already teaches that the blood flow exerts a deflection force on the flow-directed member to unfurl the flow directed member (see Belson: Abstract – “The flow-directed member can be deployed to direct the distal end of the catheter guide downstream following the blood flow in the vessel”). Chuttani merely teaches that the flow-directed member is a coil that can unfurl from a furled state (see Figure 2) into an unfurled state (see Figure 1) when subject to external forces.
In response to Applicant’s argument that the combination of Belson and Chuttani does not teach “the proximal and distal portions of the coil wire comprise a hypodermic tube” as recited in claim 17, the Examiner notes that Belson describes that the flow directed member may be mounted on a catheter of conventional construction (see [0020]), and the plain meaning of the term (per Google) “hypotube” is “A hypotube (short for hypodermic tube) is a very thin, precision-manufactured metal tube, usually stainless steel, used as a core component in medical devices like catheters, stents, and guidewires, providing structure, protection, and a pathway for delivering drugs or accessing vessels in minimally invasive procedures”. Thus, one of ordinary skill in the art would readily understand the description of a catheter of conventional construction in Belson to include a hypodermic tube.
In response to Applicant’s argument that the dimensions recited in claim 18 are not an obvious matter of design choice, the Examiner notes that Applicant has not demonstrated any criticality in the combination of recited dimensions, or provided that said dimensions solves any stated problem, is for any particular purpose, or provides any unexpected results. Rather, the recited dimensions appear consistent with lengths and diameters of typical guidewires designed for use within the vasculature, and therefore configuring the device of Belson in view of Chuttani to have such dimensions would be well within the level of ordinary skill in the art, as suggested by the rejection.
Applicant argues that Carter does not teach or suggest the coil of the distal portion possesses both shape memory and shape-ability, and therefore Belson in view of Chuttani in view of Carter does not teach or suggest “the coil of the distal portion possesses both shape memory and shape-ability, the shape-ability allowing the coil to unfurl from the furled state into the unfurled state when the deflection force of blood flow exerted on the coil is sufficient to cause the coil to unfurl from the furled state into the unfurled state”. Again, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The combination of Belson and Chuttani et al. teaches the coil of the distal portion possesses shape-ability, the shape-ability allowing the coil to unfurl from the furled state into the unfurled state when the deflection force of blood flow exerted on the coil is sufficient to cause the coil to unfurl from the furled state into the unfurled state (see Belson: Figure 3 and [0022] – “FIG. 3 shows the distal end 108 of the catheter guide 100 of FIG. 1 with the flow-directed member 104 in a deployed state. The flow-directed member 104 may be deployed by advancing the actuation wire 116 from the proximal end 106 of the catheter guide shaft 102 to push the parachute shroud 120 out of the chamber 118 on the distal end 108 of the elongated shaft 102”). Carter teaches the coil of the distal portion possesses shape memory, the shape memory causing the coil to attempt to return to the furled state from the unfurled state when the deflection force of the blood flow exerted on the coil is less than said sufficient force (see col. 6, lines 63-67 – “Any suitable material can be used for the wire guide 20 and portions thereof. The material chosen need only be biocompatible, or made biocompatible, and able to be formed into the structures described herein. Exemplary materials will also be compliant, elastic, resilient and have shape memory”).
Regarding claim 20, in response to applicant's argument that Chuttani does not disclose or suggest that the helix is unfurled by blood flow or is directed by blood flow, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Belson already teaches that the blood flow exerts a deflection force on the flow-directed member to unfurl the flow directed member (see Belson: Abstract – “The flow-directed member can be deployed to direct the distal end of the catheter guide downstream following the blood flow in the vessel”). Chuttani merely teaches that the flow-directed member is a coil that can unfurl from a furled state (see Figure 2) into an unfurled state (see Figure 1) when subject to external forces.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791